Low Back PainMc-SubLombNCT03720444
"Evaluation of the Effectiveness of the MDT Method (Mechanical Diagnosis and Therapy) in the Management of Low Back Pain in the Subacute Phase"
An observational study of Low Back Pain, run by Nantes University Hospital at 1 site in France.
Trial summary
The investigators propose to carry out a study evaluating the effectiveness of the MDT method (mechanical diagnosis and therapy) in the subacute phase of common low back pain. Few studies have specifically evaluated the effectiveness of the MDT method in the subacute phase, a phase that appears to be crucial before… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- MDT (mechanical diagnosis and therapy) method
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2019to 1 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study population is all patients aged 18 to 55 years who consult with one of the Mc Kenzie physiotherapists participating in the study, for a common low back pain reason between 4 and 12 weeks of evolution. The first ten patients consulting one of the physiotherapists involved and meeting the criteria will be recruited. Each patient will receive information about the research and sign a consent. Patients with a strong suspicion of specific low back pain will be excluded from the outset.
Who may be able to join
- Consultant patients at the Picasso physiotherapy practice (5 rue Nina Simone - 44 000 NANTES)
- Aged 18 to 55 years old
- Suffering from common-looking low back pain. Low back pain is defined as pain or localized discomfort under the 12th dorsal vertebrae and above the inner fold buttock, with possible irradiation to the lower limb but not exceeding the knee.
- Evolving for 4 to 12 weeks (subacute period).
- Period preceded by a period of 30 days without low back pain (in order to avoid recurrent low back pain, rather similar to the chronic phase).
Who cannot join
- Signs of specific low back pain (confirmed or highly suspected diagnosis): fracture, infection, osteoporosis, inflammatory disease, tumor
- Irradiation below the knee
- Patient knowing she is pregnant
- Protected adults
- Patient with proven cognitive impairment
- Patient with a decompensated psychiatric pathology
- Incapacity to consent
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
France1 site
Picasso physiotherapy cabinet (5 rue Nina Simone - 44 000 NANTES)
Nantes, 44000
Jonathan VIZZINI, vizzinikine@gmail.com
Carl GABORIT, vizzinikine@gmail.com
About this study
The investigators propose to carry out a study evaluating the effectiveness of the MDT method (mechanical diagnosis and therapy) in the subacute phase of common low back pain.
Few studies have specifically evaluated the effectiveness of the MDT method in the subacute phase, a phase that appears to be crucial before the chronicization of low back pain.
Read more
The main objective of this study will be to evaluate the pain of patients managed by the MDT method.
The analysis of the main criterion (Visual Analog Scale) will be done using a type individual clinical trial specific: the Single Case Experimental Design or SCED in lines of multiple bases.
This type of study makes it possible to carry out a comparative test on a single subject acting as its own witness in order to obtain an acceptable level of evidence response for that particular patient.
- Conditions
- Low Back Pain
- Being tested
- MDT (mechanical diagnosis and therapy) method
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDT (mechanical diagnosis and therapy) methodOther
The intervention consists of a first session to carry out an assessment, followed by 4 reassessment sessions
| Study group | Role | What they receive |
|---|---|---|
| MDT (mechanical diagnosis and therapy) method | Not described Receives: Other: MDT (mechanical diagnosis and therapy) method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution over time of patients' pain
The main outcome will be the evolution over time of patients' pain as assessed by a visual analogue scale completed daily by the patient himself.
Measured: 3 months
Secondary outcomes (5)
Evolution of the pain localization will be done on a body chart filled daily by the patient
Evolution of the pain localization will be done on a body chart filled daily by the patient
Measured: 3 months
Evolution of drug consumption through a completed questionnaire daily by the patient
Evolution of drug consumption through a completed questionnaire daily by the patient
Measured: 3 months
Evolution of functional disability through the EIFEL questionnaire
Evolution of functional disability through the EIFEL questionnaire
Measured: 3 months
Evolution of beliefs and fears through the FABQ (Fear Avoidance Belief) questionnaire
Evolution of beliefs and fears through the FABQ (Fear Avoidance Belief) questionnaire
Measured: 3 months
Evolution of psychosocial factors by STarT Back
Evolution of psychosocial factors by STarT Back
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start1 Jan 2019 (estimated)
- Primary completion1 May 2019 (estimated)
- Study completion1 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Celine BOUTON, Professor, Principal investigator, Nantes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720444
- Sponsor's protocol ID
- RC18_ 0269
- Acronym
- Mc-SubLomb
- Status last verified
- Oct 2018
- First submitted
- 24 Oct 2018
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Evaluation of the Effectiveness of the MDT Method (Mechanical Diagnosis and Therapy) in the Management of Low Back Pain in the Subacute Phase"
- ClinicalTrials.gov ID
- NCT03720444
- Acronym / sponsor ID
- Mc-SubLomb / RC18_ 0269
- Conditions
- Low Back Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 1 May 2019 (estimated)
- First posted
- 25 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose to carry out a study evaluating the effectiveness of the MDT method (mechanical diagnosis and therapy) in the subacute phase of common low back pain.
Few studies have specifically evaluated the effectiveness of the MDT method in the subacute phase, a phase that appears to be crucial before the chronicization of low back pain.
The main objective of this study will be to evaluate the pain of patients managed by the MDT method.
The analysis of the main criterion (Visual Analog Scale) will be done using a type individual clinical trial specific: the Single Case Experimental Design or SCED in lines of multiple bases.
This type of study makes it possible to carry out a comparative test on a single subject acting as its own witness in order to obtain an acceptable level of evidence response for that particular patient.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MDT (mechanical diagnosis and therapy) method | – | Other: MDT (mechanical diagnosis and therapy) method |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population is all patients aged 18 to 55 years who consult with one of the Mc Kenzie physiotherapists participating in the study, for a common low back pain reason between 4 and 12 weeks of evolution. The first ten patients consulting one of the physiotherapists involved and meeting the criteria will be recruited. Each patient will receive information about the research and sign a consent. Patients with a strong suspicion of specific low back pain will be excluded from the outset.
Key inclusion criteria (5 listed)
- Consultant patients at the Picasso physiotherapy practice (5 rue Nina Simone - 44 000 NANTES)
- Aged 18 to 55 years old
- Suffering from common-looking low back pain. Low back pain is defined as pain or localized discomfort under the 12th dorsal vertebrae and above the inner fold buttock, with possible irradiation to the lower limb but not exceeding the knee.
- Evolving for 4 to 12 weeks (subacute period).
- Period preceded by a period of 30 days without low back pain (in order to avoid recurrent low back pain, rather similar to the chronic phase).
Key exclusion criteria (8 listed)
- Signs of specific low back pain (confirmed or highly suspected diagnosis): fracture, infection, osteoporosis, inflammatory disease, tumor
- Irradiation below the knee
- Patient knowing she is pregnant
- Protected adults
- Patient with proven cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MDT (mechanical diagnosis and therapy) methodThe intervention consists of a first session to carry out an assessment, followed by 4 reassessment sessions | Other | MDT (mechanical diagnosis and therapy) method |
Primary outcome
Evolution over time of patients' pain
Time frame: 3 months
The main outcome will be the evolution over time of patients' pain as assessed by a visual analogue scale completed daily by the patient himself.
5 secondary outcomes
Evolution of the pain localization will be done on a body chart filled daily by the patient
Time frame: 3 months
Evolution of drug consumption through a completed questionnaire daily by the patient
Time frame: 3 months
Evolution of functional disability through the EIFEL questionnaire
Time frame: 3 months
Evolution of beliefs and fears through the FABQ (Fear Avoidance Belief) questionnaire
Time frame: 3 months
Evolution of psychosocial factors by STarT Back
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Celine BOUTON, Professor principal investigator
Nantes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Celine BOUTON, Professor (+33(0)244769055, celine.bouton@univ-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution over time of patients' pain (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2018.